Health Devotion Insights

Why the Benelux can be a powerful base for scaling across Europe

Thu, 05 Nov 2026 12:48:28 GMT

Europe is one market. But it does not speak with one voice.

For life sciences companies looking to scale across Europe, the opportunity is substantial.

More than 440 million people. A common European regulatory framework for many medicines. Highly developed healthcare systems. Strong scientific institutions. Sophisticated clinicians. Significant demand for healthcare innovation.

It is tempting to think of Europe as one market.

It is not.

The European Union has 24 official languages, while healthcare organisation, pricing, reimbursement, stakeholder influence, clinical practice and adoption remain strongly shaped by national and regional contexts.

A European marketing authorisation can provide access to the market from a regulatory perspective, but pricing and reimbursement decisions remain largely national or regional.

So scaling in Europe is not simply about repeating the same launch in another language.

It is about operating successfully across different healthcare systems, stakeholder environments and decision-making cultures without losing the core of the strategy.

Language is more than translation

One of the easiest mistakes in European expansion is to assume that because people speak English, language is no longer an issue.

Research into multinational organisations suggests otherwise.

Studies have shown that language diversity can influence communication, participation, knowledge sharing, sensemaking and trust within international organisations and teams.

That matters in life sciences.

he question is not only whether a payer, clinician or hospital executive understands the words being used.

The question is whether the underlying meaning travels with them.

A value proposition may be interpreted differently across healthcare systems.

A discussion that feels appropriately direct in one country may require a different approach elsewhere.

The relative influence of clinicians, pharmacists, payers, hospital management, professional societies and patient organisations can also vary significantly.

Translation can change the words.

Local experience helps translate the context.

Culture matters — without reducing countries to stereotypes

Culture should be approached carefully.

Europe cannot be usefully divided into simplistic national stereotypes, and individual behaviour should never be predicted purely from nationality.

But cultural distance is not irrelevant.

Research in international business shows that cultural differences can affect international expansion, communication, trust formation and organisational performance.

For companies expanding across Europe, the practical lesson is not to memorise lists of “Dutch”, “German” or “French” behaviours.

It is to recognise that every company has its own communication style, assumptions and decision-making habits — and that these may not produce the same response in every European market.

A strong European partner helps identify those differences before they become commercial problems.

Why the Benelux is an interesting place to start

This is where the Benelux offers an unusual perspective.

The region is geographically compact, but it already requires organisations to work across different languages, cultures, healthcare systems and decision-making environments.

The Netherlands, Belgium and Luxembourg have a long history of cross-border cooperation. The Benelux Union itself has described the region as a “laboratory for Europe”, where cross-border solutions can be developed and tested.

That description is particularly relevant to life sciences.

Within a relatively small area, companies already encounter Dutch-, French-, German- and Luxembourgish-speaking environments.

Healthcare organisation differs.

Reimbursement structures differ.

Stakeholder dynamics differ.

Even within neighbouring markets, assumptions cannot simply be copied from one country to another.

This creates an important habit:

Never assume that what works across one border will automatically work across the next.

The Netherlands adds another dimension

The Netherlands is structurally international.

According to the OECD, the combined value of Dutch imports and exports represented 159% of GDP in 2024, compared with an OECD average of 106%. Around 70% of Dutch exports went to other EU countries.

That matters because working internationally is not an occasional activity in the Dutch economy.

It is part of its structure.

The Netherlands also hosts the European Medicines Agency in Amsterdam.

That should not be exaggerated: geographic proximity to EMA does not create privileged regulatory access.

But it does contribute to a broader life sciences environment in which European regulatory science, international companies and cross-border healthcare discussions are highly visible.

Combined with Belgium’s multilingual environment and Luxembourg’s cross-border character, the Benelux becomes an interesting starting point for companies preparing to scale across Europe.

But a Benelux partner should never pretend to “know Europe”

This may be the most important point.

A Dutch or Benelux consultancy cannot credibly claim to understand every local stakeholder dynamic in France, Germany, Italy, Spain, Poland or any other European market.

Europe requires local expertise.

The value of a strong Benelux partner is therefore not that it removes the need for country expertise.

It is that it can help organise and connect it.

A strong partner can distinguish between the elements of a European strategy that should remain consistent and those that need local adaptation.

It can recognise when an English-language answer is technically correct but locally incomplete.

It can challenge the assumption that a successful Dutch reimbursement argument will automatically work in Belgium or Germany.

And it can bring the appropriate local expertise into the process before strategic decisions become difficult or expensive to change.

Europe needs both consistency and localisation

European expansion therefore requires balance.

Too much centralisation and local reality is missed.

Too much localisation and the European strategy becomes fragmented.

The objective is not to create a completely different launch strategy for every country.

Nor is it to impose one global plan on very different healthcare systems.

The objective is to determine deliberately what should remain European, what can be regional and what must be local.

That is particularly important in life sciences, where a seemingly small difference in comparator choice, clinical practice, HTA expectations, hospital financing or stakeholder influence can have a significant effect on access and adoption.

A bridge, not a replacement

This is ultimately why the Benelux can be a powerful base for companies scaling into Europe.

Not because the Netherlands, Belgium or Luxembourg represent Europe as a whole.

They do not.

But because working in this region teaches an important European lesson very quickly:

Proximity does not mean similarity.

Countries separated by an hour’s drive may speak another language, finance healthcare differently, organise decision making differently and respond differently to exactly the same proposition.

A good Benelux partner therefore should not say:

“We understand Europe for you.”

It should say:

“We know how to navigate differences, recognise when local expertise is required and connect those local realities into one coherent European strategy.”

At Health Devotion, that is how we look at European expansion.

Our role is not to replace the expertise of the company entering Europe.

Nor is it to replace local specialists in individual countries.

It is to connect them.

To preserve the strength of the global strategy while challenging assumptions against local reality.

To create one direction without pretending that Europe is one market.

And to help build the local understanding and relationships that allow strong science and innovation to become clinically and commercially relevant in Europe.

For companies scaling into Europe, that distinction can make a significant difference.

Sources

European Union — Multilingualism and official languages

European Medicines Agency — European marketing authorisation, pricing and reimbursement

OECD — Economic Survey of the Netherlands 2025

Benelux Union — Benelux cooperation and cross-border integration

Beugelsdijk et al. — Cultural distance and firm internationalisation, Journal of Management

Tenzer et al. — Language barriers, trust and communication in multinational organisations

Tenzer, Pudelko & Zellmer-Bruhn — Language and multinational teams, Journal of World Business

Explore our Benelux springboard for European market entry.

From Asian innovation to European impact

Thu, 22 Oct 2026 21:24:20 GMT

Connecting scientific expertise with European evidence and access requirements

Bringing an Asian life sciences innovation to Europe requires a connection between the company’s scientific expertise and the evidence, healthcare pathways and stakeholder questions of the intended European markets. A good local partner complements the company’s knowledge with that context.

For Taiwanese and other Asian companies considering European expansion, the starting point should be the product and its development stage. The route for a medicine differs from the route for a medical device or another healthcare technology. This article focuses on medicines, while the broader partnership principles also matter to other innovators.

Europe is not a single access decision

The EU centralised procedure provides a common authorisation route for eligible medicines: EMA conducts the scientific assessment and the European Commission issues the authorisation. Pricing and reimbursement decisions still take place at national and regional level. A European authorisation therefore does not by itself establish a funded route to patients in each country.

A market-entry plan needs to connect the regulatory pathway with evidence assessment, funding decisions and implementation in the selected markets. Country sequencing should reflect that work as well as commercial opportunity.

Consider how the evidence will travel

When clinical development has taken place mainly in another region, the question is how well the evidence supports the proposed use in Europe. ICH E5 provides a framework for considering intrinsic factors, such as physiological characteristics, and extrinsic factors, such as medical practice, when assessing the applicability of foreign clinical data.

This is not a judgement that evidence from Asia is weaker. It is a product-specific question about the relevance of the data to another population and setting. The guideline seeks to facilitate use of foreign data and avoid unnecessary duplication; additional studies are not an automatic requirement for every medicine.

Alongside regulatory applicability, a team should examine whether comparators, endpoints and care pathways address the questions likely to arise in its intended access discussions. Those questions are easier to address while the development strategy can still change.

Build a partnership around complementary knowledge

The innovator brings knowledge of the science, technology, clinical programme and home market. A European partner should add a specific understanding of the selected countries, their healthcare systems and the practical decisions required for entry.

That contribution should be visible in the work: a clear evidence-gap assessment, an explanation of local access pathways, a prioritised stakeholder map and recommendations linked to management decisions. A broad network is useful only when it helps the team ask the right questions and understand the answers.

Start with a focused feasibility discussion

Which product, indication and patient population are being considered?
Which evidence choices are still open, and which have already been fixed?
What are the proposed European countries, and why have they been prioritised?
Which regulatory, access and operational uncertainties need specialist assessment?
What local capabilities are needed now, and which can wait until the next milestone?

The output should help the company decide what to investigate, what to change and what to resource next. For a Benelux entry, assess the relevant national requirements while coordinating the work across medical, access, regulatory and commercial functions.

Connect innovation with local implementation

Trust and mutual understanding take time. A productive partnership makes room for different perspectives, records assumptions explicitly and keeps the innovator involved in the decisions. Local expertise should strengthen the company’s strategy while respecting the knowledge that made the innovation possible.

Health Devotion supports international life sciences companies with senior experience and local stakeholder understanding. Explore our Market Exploration & Validation services or discuss your European market-entry questions .

About the author: Ivo Vink , Health Devotion.

Sources: EMA: authorisation of medicines ; ICH E5(R1): acceptability of foreign clinical data .

Europe is often not planned too early. It is planned too late.

Fri, 11 Sep 2026 21:24:40 GMT

Early feasibility for European life sciences market entry

European market access preparation should begin while clinical and commercial assumptions can still be changed. Waiting until the evidence package is complete can leave a launch team with questions that a reimbursement dossier alone cannot resolve.

For life sciences companies developing a new medicine, postponing European planning is understandable. Teams want clearer clinical results, greater regulatory confidence and a more predictable investment case. Yet decisions about comparators, endpoints and patient subgroups may already be taking shape. Those decisions can influence the questions that European clinicians and assessment bodies will later ask.

Start before important choices become difficult to change

There is no single development phase that is right for every product. The useful moment is before pivotal study design and other consequential evidence choices are locked. A focused feasibility review at that point can identify which assumptions need testing and which decisions can still be influenced.

This does not require committing to a full affiliate or a complete launch organisation. It means giving European access requirements a place in development discussions early enough to matter.

What should an early feasibility review test?

Clinical relevance: do the proposed comparator, endpoints and patient population reflect the treatment decisions in the intended markets?
Evidence gaps: which uncertainties could matter to assessment bodies, clinicians or local budget holders?
Economic assumptions: does the value story consider the relevant care pathway, resource use and budget impact?
Country sequencing: is the proposed first market supported by access readiness, or mainly by an attractive market-size estimate?
Adoption: who influences treatment decisions, and what practical barriers could remain after reimbursement?

Combine formal requirements with local experience

Published guidance is essential, but it does not answer every operational question. Senior local input can help a team understand how clinical practice, hospital decisions, pharmacy processes and funding arrangements interact. In the Benelux, that work needs to distinguish the Netherlands, Belgium and Luxembourg rather than treating them as interchangeable.

Formal scientific advice can also support evidence planning. EMA and the European HTA Coordination Group offer parallel joint scientific consultations for eligible developments, addressing regulatory and HTA evidence questions through their respective processes. Such advice complements local feasibility work; a consultant’s assessment does not replace it or guarantee an outcome.

Make the output useful for decisions

A practical review should leave the team with a prioritised assumption register: what is known, what remains uncertain, how each uncertainty could affect the launch, and who will investigate it. Each finding should connect to a decision, an owner and a development milestone.

The aim is to identify avoidable problems while options remain open. No review can promise access or eliminate delay. It can help management make a more informed decision about evidence generation, country sequencing and the next investment.

Discuss your European launch assumptions

At Health Devotion, we combine senior life sciences experience with local stakeholder understanding to challenge market-entry assumptions. Explore our Market Exploration & Validation services or contact us to discuss your development and launch questions.

About the author: Ivo Vink , Health Devotion.

Source: EMA: collaboration with health technology assessment bodies .

Market access is not written. It is built.

Sat, 08 Aug 2026 21:24:45 GMT

Why market access starts before the reimbursement dossier

A reimbursement dossier is an important output of market access work. It is not the whole process. For a life sciences launch, evidence, local relevance and practical adoption need attention well before the submission is written.

A dossier can be robust and coherent while important questions remain unanswered: does the product address the clinical need as local clinicians see it? Is the comparator relevant? Can hospitals incorporate the treatment into their existing pathway? Which budget pays, and who needs to make the operational decisions?

Separate authorisation, reimbursement and adoption

These are connected but distinct steps. EMA explains that, after a European marketing authorisation, pricing and reimbursement decisions take place at national and regional level. EMA itself does not decide pricing or reimbursement.

Even where funding is available, a launch team still needs to understand how patients will reach the treatment, how clinicians will use it and which organisational changes are needed. A market access strategy should therefore follow the patient pathway as well as the formal assessment route.

Build the evidence story while choices are open

Late writing cannot change the comparator used in a completed trial or add a missing outcome retrospectively. That is why access questions should inform development discussions while there is still scope to act.

Test whether endpoints address the outcomes relevant to the intended assessment and clinical decisions.
Examine comparator choices against local standards of care and likely changes before launch.
Identify patient subgroups and uncertainties that could influence the interpretation of value.
Check economic assumptions against the relevant care setting and resource use.
Plan how genuine evidence gaps could be addressed, rather than hiding them behind a stronger narrative.

Understand the people behind the pathway

Stakeholder understanding is more specific than a list of influential names. Clinicians, pharmacists, hospital management, payers, budget holders, professional groups and patient organisations may each see a different part of the problem.

Purposeful, appropriate engagement can reveal practical questions that desk research misses. A team might discover that an administration requirement affects staffing, that a referral pathway is poorly defined, or that the perceived target population differs from its original forecast. These insights should improve the plan, not merely decorate a stakeholder map.

Turn local insight into a working access plan

Assign each important assumption an owner and a clear next step. Distinguish confirmed requirements from interpretation, and record where stakeholders disagree. Connect medical, access, regulatory and commercial work so that new information changes the launch plan when it needs to.

For the Benelux, that means testing the relevant country and care setting. A regional strategy can coordinate the work, but it should not erase differences between national systems or local implementation.

What should be ready before the dossier?

The team should be able to explain the intended place in therapy, the evidence supporting it, the unresolved uncertainties and the practical route to patient access. The dossier then expresses a strategy that has already been examined, rather than becoming the first moment at which those questions are considered together.

At Health Devotion, we believe market access is built through early preparation, credible evidence and local understanding. Read about our life sciences services or discuss your access questions with us .

About the author: Ivo Vink , Health Devotion.

Source: EMA: authorisation of medicines and patient access .

Five questions before you trust your launch advice.

Mon, 20 Jul 2026 21:24:52 GMT

A practical quality check for European life sciences launch advice

Useful launch advice should identify the local assumptions behind a recommendation, explain what could challenge them and show which management decision would change. A convincing presentation is only the starting point.

Before entering a new European life sciences market, executives need to distinguish informed local judgement from a strategy that could have been written for almost any country. These five questions provide a practical way to challenge the advice without having to become the local expert yourself.

1. Which local assumption is most likely to fail first?

“Payers may challenge the price” is too broad to guide a decision. Ask which assumption is vulnerable: comparator choice, endpoint relevance, budget impact, treatment pathway, procurement process or intended place in therapy.

A useful answer identifies the specific issue, explains the evidence behind the concern and describes what should be tested next. It also distinguishes a documented requirement from an experienced adviser’s interpretation.

2. Who can influence adoption before formal access?

A list headed “KOLs and payers” is not a stakeholder strategy. Ask which clinical groups, hospital stakeholders, pharmacists, patient organisations and budget holders can influence how the product’s role is understood.

The answer should explain their role in the care pathway and the questions they are likely to raise. It should also show where the team needs genuine input, rather than assuming that stakeholder engagement means delivering a message that has already been finalised.

3. What evidence may be challenged locally?

Good advice examines the limitations as well as the strengths of a data package. Which endpoints, comparators, subgroups, real-world evidence gaps or economic assumptions may attract questions in the intended market?

Ask what additional work could resolve the uncertainty and whether it can still affect development or launch decisions. An adviser should be comfortable saying where the available information does not yet support a firm conclusion.

4. Is country sequencing based on access readiness or market size?

A large potential market is not automatically the best first market. Compare the opportunity with evidence fit, the access route, operational requirements, stakeholder understanding and the resources required to execute.

Ask why the proposed sequence is preferable to a realistic alternative. A useful recommendation makes the trade-offs explicit and identifies the conditions under which the sequence should change.

5. What are competitors already shaping?

A competitor table should go beyond products that are approved, priced or reimbursed. Ask how competitors may affect guidelines, treatment habits, procurement expectations, price references and the evolving standard of care.

The answer should separate observable developments from speculation. It should also consider the environment at the expected launch date, rather than assuming that today’s market will remain unchanged.

Turn the answers into a quality test

For each recommendation, ask: what would make it wrong? Who locally might disagree? Which assumption should be tested first? What management decision changes if the advice is correct?

In the Benelux, apply those questions to the specific country and care setting. Regional experience is valuable, but an answer should still explain the relevant local differences. The strongest advisers connect practical experience with evidence and are clear about the limits of both.

Health Devotion uses focused feasibility work to help leadership teams test launch assumptions. Explore our Market Exploration & Validation services or discuss the questions behind your launch plan .

About the author: Ivo Vink , Health Devotion. This article presents a practical framework for assessing launch advice.

Fractional-first teams in life sciences: a private equity perspective

Mon, 19 Jan 2026 21:24:57 GMT

Governance, flexibility and the path to a permanent Benelux organisation

A fractional-first operating model uses experienced professionals for defined work before a company commits to a larger permanent organisation. For private equity investors in life sciences, its value depends on how the work is governed, how knowledge is retained and when the organisation will need to internalise capacity.

The choice is often framed as building a local affiliate early or remaining flexible for as long as possible. A more useful question is which capabilities are needed at each stage, and how the company will move between stages without losing continuity or control.

Define the model before comparing the cost

In this article, fractional-first means engaging senior specialists or a coordinated team on clearly defined mandates, with agreed deliverables, scope, timing and decision rights. It can support medical strategy, market access, regulatory coordination and commercial preparation.

The label alone does not tell an investor how the business operates. An individual adviser, an interim executive and a multidisciplinary team may solve different problems. Compare the actual work and responsibilities, not simply the day rate or the number of external people.

The trade-off: fixed commitments and organisational uncertainty

An early affiliate can provide continuity, dedicated capacity and internal knowledge. It also creates fixed costs before local demand and the access pathway are fully understood. In smaller markets, those commitments deserve careful testing against realistic scenarios.

External expertise can make capacity more adaptable, but flexibility has its own costs. Poor coordination, unclear ownership and repeated handovers can slow decisions. A model that appears inexpensive can become difficult to manage if important knowledge stays with individuals outside the organisation.

The investment case should therefore compare total cost and execution capability under several uptake and timing scenarios. A lower initial cost does not by itself demonstrate a stronger operating model.

Where focused senior expertise can help

Early market entry often requires judgement at specific moments: testing an access strategy, mapping the care pathway, reviewing evidence assumptions or designing launch readiness. Those tasks may need deep experience before they need a large team.

A coordinated group can help connect medical, access, regulatory and commercial perspectives. The benefit depends on how the team works together and how its findings reach the people making decisions. Adding several independent specialists without a shared plan does not automatically create a team.

Make governance explicit

Ownership: name the accountable sponsor and the person authorised to make each material decision.
Scope: define deliverables, boundaries, dependencies and escalation routes.
Responsibilities: document the relevant regulatory and compliance roles for the product, country and activities.
Knowledge: keep assumptions, contacts, decisions and working documents in systems the company can retain.
Review: agree how progress, quality and changing requirements will be assessed.

Contract wording should match the real working arrangement. The appropriate allocation of responsibilities and employment or contractor status requires assessment for the specific situation; “fractional” is not a legal exemption or a guarantee of compliance.

Decide when to internalise

Plan the transition before it becomes urgent. Useful review triggers include a more stable access position, clearer recurring workload, an expanding portfolio, sustained demand for local execution or a growing need for continuous internal coordination.

These are prompts for a decision, not universal thresholds. Some specialist work may remain external while other capabilities become permanent. Define who will make that decision, which evidence they will use and how the handover will work.

Questions for investor diligence

What would the operating model cost under delayed, base-case and faster uptake?
Which costs are genuinely variable, and which commitments remain?
Who holds decision authority and owns cross-functional coordination?
Can the company retain the knowledge needed if a provider changes?
What is the expected cost, timing and operational impact of internalisation?

In the Benelux, assess the work country by country while identifying where regional coordination is useful. Avoid assuming that a compact geography removes differences in access processes or stakeholder environments.

Flexibility needs a destination

A fractional-first model can be a deliberate stage in building a business. Its strength lies in connecting flexible expertise to a clear operating plan, with ownership and transition decisions made visible from the start.

Explore Health Devotion’s Business Setup & Implementation services or discuss the team and capabilities your next stage requires .

About the author: Ivo Vink , Health Devotion. This article offers an operating-model perspective for life sciences leaders and investors.